Pre-Validation Requirements: Specificity: Linearity and Range: Accuracy and Precision: Robustness: Limit of Detection & Quantitation: System Suitability: Observations and Deviations: Analytical test method validation is a cornerstone of scientific accuracy and precision. Read also:
Good Manufacturing Processes (GMPs) for Quality Assurance GMPs are the backbone of consistent and controlled production of products, meeting the required quality standards for their intended use. They cover both production and quality control, ensuring excellence in the manufacturing process. Good Clinical Practice (GCP) for Ethical Trials GCP sets the gold standard for designing,…
Good Laboratory Practices (GLP) play a crucial role in ensuring the integrity, reliability, and ethical conduct of nonclinical safety studies. Let’s delve into why companies emphasize GLP compliance: 1. Regulatory Requirements: GLP regulations provide a standardized framework for conducting nonclinical studies in drug development. Regulatory agencies, such as the FDA and EMA, mandate…
Risk assessment plays a crucial role in the pharmaceutical industry due to its impact on public health, regulatory compliance, and business success. Here are some key points highlighting its importance and impact: Patient Safety: Risk assessment ensures that pharmaceutical products are safe for consumption by identifying and mitigating potential risks associated with their development,…
3 Types of Water System Validation: Water System Validation Phase I Water System Validation Phase II Water System Validation Phase III 1. Water System Validation Phase I The time period for phase I shall be 2 to 4 weeks (14 days minimum) to Examine the system thoroughly. During this time, the operation must operate…
What are the 4 types of validation? A) Prospective validation B) Retrospective validation C) Concurrent validation D) Revalidation How many stages for process validation life cycle? Process Design: Process design is the first stage of the process validation life cycle approach. Design the manufacturing process of the subject product based on the knowledge gained…
Purity Purity refers to the degree to which a substance is free from impurities or contaminants. In pharmaceuticals and chemicals, purity is a critical parameter because impurities can affect the safety, efficacy and stability of the final product. Purity is usually expressed as a percentage and can be determined through various analytical techniques such as…
Once the dosage form reaches the absorption site, it must disintegrate, deaggregate and release its therapeutic agent. The lack of ability of a drug to go into solution is sometimes a more important limitation to its overall rate of absorption than its ability to permeate the intestinal mucosa. For many drugs that cross the intestinal…
